What cGMP analytical testing services does Solvias offer for biologics drug development?
Solvias provides a comprehensive suite of cGMP-compliant analytical testing services for biologics, including method development, validation, release testing, stability studies, and structural characterization. Our state-of-the-art bioassay labs support a wide range of biologics, from monoclonal antibodies to complex fusion proteins, ensuring data integrity and regulatory readiness across global markets.
Which cell-based bioassay development services are available for biologics and ATMPs?
We specialize in custom cell-based bioassay development for advanced therapy medicinal products (ATMPs), cell and gene therapies and biologics. We design assays that accurately measure potency, mode of action, and biological activity using primary cells or engineered cell lines, backed by robust validation under GMP conditions.
What genetic quality control testing services are available for cell and gene therapy products?
Solvias offers robust genetic QC services such as vector copy number, integration site analysis and genetic stability. These services support safe and consistent manufacturing of cell and gene therapy products, aligned with EMA and FDA guidance.
What capabilities does Solvias offer for antibody–drug conjugate (ADC) drug-antibody ratio (DAR) analysis and payload linker characterization?
We provide specialized analytics for antibody–drug conjugates (ADCs), including drug-antibody ratio (DAR) analysis, payload quantification, linker stability assessment, and site-specific conjugation profiling. Our bioconjugation expertise ensures critical quality attributes (CQAs) are measured accurately to support process development and release.
What analytical services does Solvias offer for peptide drug development?
Solvias provides end-to-end peptide analytical services, from raw material characterization to final drug product release. Our cGMP-compliant offerings include impurity profiling, identity and structure confirmation, higher-order structure (e.g., CD, FT-IR, NMR), aggregation state analysis (e.g., SEC-MALS, DLS, AUC), potency and biosafety testing (e.g., ELISA, SPR, endotoxin, sterility), stability studies, and impurity/by-product monitoring.
What solutions are available for oligonucleotide characterization and testing?
Solvias offers oligonucleotide analysis for raw materials,drug substance/comparability analysis and drug product release testing under both GMP and ISO standards. These services span from pre-clinical to commercial phases.
What analytical characterization services are available for small molecule pharmaceutical control strategies?
Solvias supports small molecule drug development with full analytical characterization including identity confirmation, potency, purity, polymorphism, particle size distribution, and residual solvent analysis. We help define a robust control strategy aligned with ICH Q8–Q11 principles for risk-based quality assurance.
How does Solvias’ small molecule pharmaceutical characterization support oral inhalation (OINDP) and nasal drug products?
We provide specialized analytical services for orally inhaled and nasal drug products (OINDPs), including particle size analysis (e.g., cascade impaction), aerodynamic assessment, and dose uniformity. Our GMP-compliant labs ensure your products meet FDA and EMA expectations for locally and systemically acting therapy.
What analytical method development and validation services does Solvias provide under ICH Q2(R2) guidelines?
Our scientists offer full lifecycle support for analytical method development, optimization, transfer, and validation in alignment with ICH Q2(R2). Services include HPLC, GC, CE, spectroscopy, and bioassay-based methods across small molecules, biologics, and complex modalities—delivered with precision and speed.
Can Solvias perform solid-state analysis for drug substances and formulations?
Yes—Solvias delivers a broad array of solid-state and physical characterization techniques under GMP. These include X-ray diffraction (XRD/XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapor sorption, microscopy, porosity, particle size metrics, and more.
How does Solvias perform high-resolution mass spectrometry (HRAM LC MS/GC MS) impurity screening and structure elucidation?
Solvias utilizes high-resolution accurate mass spectrometry (HRAM-LC-MS and GC-MS) for targeted and untargeted impurity profiling. Our experts interpret MS/MS fragmentation patterns and use spectral libraries to confidently identify unknowns, accelerating root cause investigations and regulatory submissions.
Can Solvias perform impurity profiling for nitrosamines and genotoxic impurities?
Yes, Solvias offers advanced impurity profiling services, including identification and quantification of nitrosamines, genotoxic impurities (GTIs), and residual solvents in new chemical entities (NCEs). Our labs use sensitive techniques such as LC-MS/MS, GC-MS, and high-resolution mass spectrometry to ensure regulatory compliance and patient safety.
How can Solvias support residual solvent testing in compliance with ICH Q3C and USP requirements?
Solvias performs residual solvent analysis using validated headspace GC methods aligned with ICH Q3C and USP <467> guidelines. We can screen for Class 1, 2, and 3 solvents, provide method development for new compounds, and deliver high-quality documentation for global regulatory filings.
What is Solvias’ approach to integrating physical and chemical methods in orthogonal structural analysis for peptides and oligonucleotides?
We apply an orthogonal suite of techniques; including peptide mapping with HR-MS, CE-MS, CD, UV/fluorescence spectroscopy, NMR, and HDX-MS to comprehensively assess structure, modifications, and higher-order conformations.
Does Solvias offer ligands and catalysts for synthesis?
Solvias supplies a robust portfolio of high-performance ligands and catalysts to support diverse chemical synthesis needs that enhance process development.
Does Solvias support method transfer and validation for solid-state and peptide analyses?
Yes. We provide method development, optimization, transfer, and validation for techniques like DSC, XRD, LC-MS, and peptide impurity profiling under ICH Q2(R2) and cGMP requirements.
Does Solvias offer extractables and leachables testing services for pharmaceutical packaging safety?
We offer end-to-end extractables and leachables (E&L) services that meet regulatory guidelines such as USP <1663>/<1664> and ISO 10993. Solvias supports materials selection, method development, simulation studies, and toxicological risk assessments—ensuring your pharmaceutical packaging is safe and compliant throughout its lifecycle.
What combination-product testing services does Solvias offer for autoinjector-based therapies?
Solvias provides comprehensive combination-product (drug + device) testing for autoinjectors, including tests such as action force, break loose and glide force. In addition to functional performance, we can offer extractables & leachables (E&L), container-closure integrity testing (CCIT), and stability studies to support regulatory readiness across global markets.
Can Solvias test autoinjectors handling peptide,oligonucleotide and biologic formulations?
Yes, Solvias’ autoinjector testing capabilities—including functional performance, CCIT, E&L, and stability studies—support peptide, oligonucleotide, and biologics in delivery devices.
Which microbial testing and container closure integrity testing (CCIT) services does Solvias provide for sterile and non-sterile pharmaceutical products?
Our microbial testing services include bioburden, endotoxin, sterility, and microbial limits testing, all performed in GMP-compliant labs. We also conduct dye ingress, helium leak, and microbial ingress container closure integrity (CCI) testing to ensure sterility assurance for injectable and ophthalmic products.
How does Solvias ensure stability testing of drug substances across ICH zones I–V?
Solvias conducts accelerated and long-term stability studies under ICH Q1A(R2) guidelines for all climate zones. We manage everything from protocol design and chamber storage and reporting, supporting both registration and commercial supply chain robustness for global regulatory submissions.
Can Solvias develop and validate potency assays aligning with FDA and EMA requirements for commercial drug release?
Yes, Solvias develops and validates potency assays. Our scientists use techniques such as cell-based bioassays, ELISA, and reporter gene assays, delivered under GMP, to ensure reliable commercial batch release data for global health authorities.
What process analytical technology (PAT) products, such as fiber optic probes, does Solvias offer for real-time process monitoring?
Solvias offers advanced process analytical technology (PAT) tools including fiber optic Raman and NIR probes for in-line and real-time monitoring. These solutions enable robust process control in pharmaceutical manufacturing, supporting QbD approaches and reducing batch variability.
What kind of company is Solvias, and where is it headquartered?
Solvias is a globally recognized contract research, development, and manufacturing organization (CRO) specializing in analytical and scientific solutions for the pharmaceutical, biopharmaceutical and biotech industries. Headquartered in Kaiseraugst, Switzerland, we have a strong presence across Europe and North America, supporting drug developers with the tools and expertise to accelerate product development and ensure regulatory compliance.
What is the Solvias mission?
Our mission is to help bring safe, effective therapies to market faster by providing the highest standards in scientific rigor and quality. We are committed to advancing human health by partnering with pharmaceutical innovators to solve complex challenges from discovery and innovation through commercialization.
How does Solvias ensure quality control across different therapeutic modalities?
With cGMP compliance, ISO certifications, mutual recognition for global markets, and a highly controlled QA system including Qualified Persons (QP) for batch release, Solvias ensures consistent quality across small molecules, biologics, novel modalities, and combination products.
What do customers say about working with Solvias?
Customers consistently highlight Solvias’ scientific expertise, responsiveness, and reliability as key differentiators. Many clients describe our team as an extension of their own; trusted partners who go above and beyond to help overcome technical challenges, meet regulatory milestones, and accelerate time to market. Testimonials often emphasize our collaborative spirit, quality-driven mindset, and commitment to scientific expertise and excellence.
